NCT03438734

Brief Summary

Obesity is a chronic disease that affects quality and duration of life negatively. It's not clearly known the effects of low flow anesthesia on cerebral oxygenation with high-risk morbidly obese patients. In this study, it was aimed to compare the effects of general anesthesia with low flow (0,75 L/min) and normal flow (1,5 L/min) on cerebral oxygenation and depth of anesthesia in morbidly obese patients in bariatric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

February 6, 2018

Last Update Submit

April 13, 2018

Conditions

Morbid ObesityAnesthesia AwarenessAnesthesia Complication

Keywords

Bariatric surgeryLow flow anesthesiaBispectral indexRegional cerebral oximetry

Outcome Measures

Primary Outcomes (1)

  • Regional Cerebral Oxygen Saturations (Left and Right)

    The measurement of Regional Cerebral Oxygen Saturations by cerebral oximetry method which estimates regional tissue oxygenation by transcutaneous measurement on the frontal cortex. Cerebral oximeter (or named as NIRS, Near-infrared spectroscopy) is a monitor used following the adequacy of cerebral perfusion with noninvasive and continuous measurement and reflects regional saturation

    From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours

Secondary Outcomes (4)

  • Heart rate

    From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours

  • Systolic and Diastolic Arterial Pressure (both)

    From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours

  • End-tidal carbon dioxide (EtCO2)

    From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours

  • Bispectral Index (BIS)

    From beginning of anesthesia (15 minutes before anesthesia) to end of anesthesia (15 minutes after anesthesia) up to nearly 5 hours

Study Arms (2)

Low flow

ACTIVE COMPARATOR

Anesthesia was maintained with desflurane inhalation with a flow of 2 L/min in 0.5 O2 oxygen-air mixture in both groups. While target minimum alveolar concentration (MAC) was 1-1.5 and the flow rate was adjusted to 0.75 L/min. Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients. The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of Bispectral Index (BIS, Bispectral Index, Monitoring System) decreases with the deepening of anesthesia.

Device: Regional cerebral oxygen saturationDevice: Bispectral Index (BIS)

Normal flow

SHAM COMPARATOR

Anesthesia was maintained with desflurane inhalation with a flow of 2 L/min in 0.5 O2 oxygen-air mixture in both groups. While target minimum alveolar concentration (MAC) was 1-1.5 and the flow rate was adjusted to 1.5 L/min.Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients. The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of Bispectral Index (BIS, Bispectral Index, Monitoring System) decreases with the deepening of anesthesia.

Device: Regional cerebral oxygen saturationDevice: Bispectral Index (BIS)

Interventions

Regional cerebral oxygen saturationDEVICE

Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients.

Also known as: NIRS (Near-infrared spectroscopy system)
Low flowNormal flow
Bispectral Index (BIS)DEVICE

The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of BIS decreases with the deepening of anesthesia.

Also known as: BIS
Low flowNormal flow

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18-65 years
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiology score I-III,
  • years,
  • BMI\> 35

You may not qualify if:

  • American Society of Anesthesiology IV,
  • Under 18 years,
  • Over 65 years,
  • Obstetric patients,
  • Uncontrolled diabetes mellitus, cardiovascular and pulmonary disease,
  • Cerebrovascular disease,
  • Patients who refused informed consent forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sedat AKBAS

Malatya, Türkiye-Türkçe, 44090, Turkey (Türkiye)

Location

Related Publications (3)

  • Jones KB Jr. Experience with the Roux-en-Y gastric bypass, and commentary on current trends. Obes Surg. 2000 Apr;10(2):183-5. doi: 10.1381/096089200321668659. No abstract available.

    PMID: 10782184BACKGROUND

  • Vegh T. Cerebral Oximetry in General Anaesthesia. Turk J Anaesthesiol Reanim. 2016 Oct;44(5):247-249. doi: 10.5152/TJAR.2016.26092016. Epub 2016 Oct 1. No abstract available.

    PMID: 27909605BACKGROUND

  • Kupisiak J, Goch R, Polenceusz W, Szyca R, Leksowski K. Bispectral index and cerebral oximetry in low-flow and high-flow rate anaesthesia during laparoscopic cholecystectomy - a randomized controlled trial. Wideochir Inne Tech Maloinwazyjne. 2011 Dec;6(4):226-30. doi: 10.5114/wiitm.2011.26256. Epub 2011 Dec 20.

    PMID: 23255984RESULT

MeSH Terms

Conditions

Obesity, MorbidIntraoperative Awareness

Interventions

Spectroscopy, Near-InfraredConsciousness Monitors

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsIntraoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesSurgical EquipmentEquipment and Supplies

Study Officials

  • Sedat AKBAS

    Inonu University Medical Faculty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: Prospective Randomized Clinical Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 20, 2018

Study Start

November 8, 2017

Primary Completion

January 17, 2018

Study Completion

February 17, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)